Intensive Goal Training for Adolescents With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530982
• Other study ID #: 54597916.1.0000.5149
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2019
• Source: Federal University of Minas Gerais
• Contact: MARINA B BRANDAO, PhD
• Phone: 3188396466
• Email: marinabbrandao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities. The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.

Description:

We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP. Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks. Moreover, they will be asked to daily practice these activities at home along the intervention period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Medical diagnosis of bilateral CP;

• Age between 12 and 17 years old;

• Manual Ability Classification System (MACS) ranging from levels I to III;

• Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;

• Ability to understand verbal instructions.

Exclusion Criteria:

• Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Intensive goal training
Intensive goal training : 30 hours during 2 weeks

Locations

Country	Name	City	State
Brazil	Associação Mineira de Reabilitação	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30. — View Citation

Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. Review. — View Citation

de Brito Brandão M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Goals	Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Primary	Change in Daily functioning- Self-Care	Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Primary	Change in Daily functioning- Mobility	Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary	Change in Manual dexterity	Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary	Change in Gross motor function	Gross Motor Function Measure (GMFM): gross motor function abilities assessed in activities from 5 domains: lying and rolling; seating; crawling and kneeling; standing; walking, running and jumping. higher scores, better outcome	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary	Change in Participation at home	Participation Environment Measure: Children and Youth (PEM-CY): Structured questionnaire to assess the frequency and level of involvement in daily living tasks (home scale will be used) higher scores, better outcomes	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary	Change in Participation in household activities	Children´s Helping Out: Responsibility, Expectations and Supports (CHORES): structured questionnaire to assess the frequency and level of assistance in household activities: higher scores, better outcomes	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up